Atreca IPO: What You Need To Know

Cancer biotechs are the hottest among drug development companies, given the lucrative market opportunity before them. One such company is testing the IPO waters this week.

The IPO Terms

Redwood, California-based oncology biotech Atrecplans to offer 7.35 million shares of its Class A common stock this week, according to the S-1/A filing from June 10. The offering is estimated to be priced in the range of $16-$18, rendering the size of the offering at about $125 million at the mid-point of the estimated price range.

Since the company qualifies as an “emerging growth company” under the SEC rules, it is subject to reduced public company reporting requirements.

The company has applied for listing its shares on the Nasdaq under the ticker symbol BCEL.

Cowen, Evercore ISI and Stifel are among the underwriters for the IPO.

The Company

Atreca is a biopharma company that uses its differentiated platform to discover and develop antibody-based immunotherapies to treat a range of solid tumor types. Unlike the traditional oncology drug discovery approaches, Atreca uses human immune system to lead it to unique antibody-target pairs from patients experiencing a clinically meaningful active immune response against their tumors.

The company’s lead product candidate ATRC-101 is a monoclonal antibody, which reacts in vitro with a majority of human ovarian, non-small cell lung, colorectal and breast cancer samples from multiple patients. ATRC-101 has demonstrated robust anti-tumor activity as a single agent in multiple preclinical models.

Atreca plans an IND filing for the candidate in late 2019 and initiate a Phase 1b trial in patients with solid tumors in early 2020.

The Finances

Atreca generated a loss of $37.94 million in fiscal year 2018, wider than the loss of $27.53 million in the year-ago period. For the third quarter ended March 2019, the loss was $13.58 million.

https://www.benzinga.com/general/biotech/19/06/13935940/atreca-ipo-what-you-need-to-know

IQVIA target raised to $178 from $167 by Stifel

Maintains Buy

https://www.benzinga.com/stock/IQV/ratings

Melinta: FDA Accepts Application for Bacterial Pneumonia Candidate

Application Seeks to Expand Label to Include an Indication and Phase III Data for the Treatment of Adult Patients with Community-Acquired Bacterial Pneumonia (CABP) ~

~ PDUFA Date Set for October 24, 2019 ~

Melinta Therapeutics, Inc. (NASDAQ: MLNT), a commercial-stage company focused on the development and commercialization of novel antibiotics to treat serious bacterial infections, today announced the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for BAXDELA^® (delafloxacin) for priority review. The sNDA filing seeks to expand the current indication for BAXDELA to include adult patients with community-acquired bacterial pneumonia (CABP).

The FDA granted priority review status based on the previous Qualified Infectious Disease Product (QIDP) designation, which provides certain incentives for the development of antibacterial and antifungal treatments for serious or life-threatening infections. Through this process, the FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date (proposed review deadline) of October 24, 2019.

https://www.marketscreener.com/MELINTA-THERAPEUTICS-INC-55126386/news/Melinta-Therapeutics-Announces-U-S-FDA-Acceptance-of-Supplemental-New-Drug-Application-for-BAXDELA-28780345/

Merck Seeks More Deals

Merck & Co. is searching for small and midsize deals, including more transactions aimed at expanding its portfolio of cancer treatments beyond the company’s top-selling product Keytruda, according to people familiar with the matter.

Merck has been buying cancer drugmakers with promising therapies and technologies. This month, Merck bought Tilos Therapeutics Inc. for $773 million. In May, it agreed to acquire Peloton Therapeutics Inc. for $1.1 billion.

The goal of the deal making is to both capitalize on the strength of Keytruda and further broaden the company’s non-oncology products, the people said. Merck is also interested in similarly sized deals that would add to its offerings of vaccines and animal-health medicines, the people said.

Keytruda, which unleashes a patient’s own immune system to fight tumors, was once an afterthought buried in Merck’s research-and-development pipeline but has in the past few years become a commercial juggernaut for the company.

The immunotherapy, whose approvals include treating 12 different types of tumors, rang up $7 billion in global sales last year and is projected to be the world’s top-selling drug by 2024, according to research firm EvaluatePharma.

Keytruda’s success has lifted Merck’s market capitalization to a record $217 billion. Since the company released positive study results for Keytruda in April 2018, Merck shares have risen 44%, compared with the S&P 500’s 9% gain.

Now some investors and analysts are starting to worry that Merck may be too dependent on Keytruda for growth. By 2024, Merck’s $20 billion in cancer-drug sales will be nearly 40% of company revenue, JPMorgan Chase & Co. projects. Merck also sells other prescription drugs, in addition to its vaccines and animal-health medicines.

“There is an emerging view, ‘Are they too tied to'” Keytruda, Credit Suisse AG analyst Vamil Divan said in an interview.

Merck is expected to address the concerns and outline its strategy Thursday, when the company holds its first investor day in five years and plans to discuss its pipeline of experimental drugs.

Among the likely topics is the company’s vaccines in development, including a potential competitor to Pfizer Inc.’s big-selling Prevnar vaccine, which protects against infections such as pneumonia and meningitis. JPMorgan analysts project Merck’s drug could reach sales of $1.5 billion.

Merck is also developing treatments for HIV/AIDS, chronic cough and heart failure.

The company is investing in its animal-health unit, which sells products for pets and livestock animals. In December, it acquired animal-tech company Antelliq Group for $2.4 billion. Merck is exploring Keytruda as a treatment for pets with cancer, according to a person familiar with the matter.

Yet outside of the company’s pipeline of cancer drugs, analysts haven’t been impressed with Merck’s drugs in development. Dr. Divan of Credit Suisse said the experimental drugs and vaccines target markets that other companies have struggled to succeed in or that are highly competitive.

“It’s up to them to show why they can do better than other companies have in these areas before,” Dr. Divan said.

Cancer, too, is a highly competitive market, which analysts and industry officials expect will get only more competitive as big drugmakers such as GlaxoSmithKline PLC try to build up a presence after staying away.

The intense interest has driven deal making in the sector — and raised premiums for cancer-drug startups. The latest deal came Monday, when Pfizer agreed to pay a 62% premium to buy Array BioPharma Inc. for $10.6 billion.

https://www.marketscreener.com/MERCK-AND-COMPANY-13611/news/Merck-Seeks-More-Deals-28779669/

Amphastar to Get $59.9 Million in Settlement With Momenta, Sandoz

Amphastar Pharmaceuticals Wednesday said it will receive nearly $60 million from Momenta Pharmaceuticals and a unit of Novartis AG after the companies agreed to settle their long-running litigation related to generic versions of the blood-thinner Lovenox.

Amphastar, a Rancho Cucamonga, Calif., specialty pharmaceutical company, said Novartis’ Sandoz and Momenta will pay $59.9 million by July 2 as part of the settlement, under which the companies will dismiss all pending litigation.

Momenta and its partner Sandoz filed a patent-infringement suit against Amphastar in 2011, seeking more than $900 million in damages, after the U.S. Food and Drug Administration approved Amphastar’s generic version of Sanofi’s (SNY) Lovenox. Amphastar later countered with an antitrust suit against Momenta and Sandoz.

https://www.marketscreener.com/AMPHASTAR-PHARMACEUTICALS-16783932/news/Amphastar-to-Get-59-9-Million-in-Settlement-With-Momenta-Sandoz-28780402/

In D.C., Diabetes is Twice the National Average East of the Anacostia River

Statistics for type 2 diabetes in Washington, D.C., neighborhoods East of the Anacostia River (Wards 7 and 8) are quite alarming. D.C. Health suggests that 13.4 percent of residents living in Wards 7; and 19.7 percent of residents in Ward 8 have diabetes (highest in the city). Comparatively, only 3.6 percent of residents living in Ward 2 have diabetes; and 4.2 percent of residents in Ward 3 (lowest in the city).

In fact, African American D.C. residents have some of the highest mortality rates (twice the national average) from type 2 diabetes and its complications. In Wards 7 and 8, the mortality rate is a stark 45 percent and 32 percent for residents diagnosed with the disease compared to 7 percent and 10 percent of residents in Ward 2 and 3.

“Diabetes is a growing epidemic among low income neighborhoods and a leading cause of chronic health issues for African Americans,” says Dr. Gail Nunlee-Bland, director of the Howard University Hospital Diabetes Treatment Center. “This disparity stems from poor communities having a lack of access to healthcare, educational programs and nutritional resources in comparison to areas of more affluence.”

Higher diabetes rates among African Americans are not unique to Washington, D.C. In the U.S., African Americans are twice as likely to develop type 2 diabetes compared to whites. This disproportion is due to a number of behavioral, environmental and socioeconomic factors. Additionally, many individuals who are at-risk don’t know they have the disease, which places their health in jeopardy from complications such as heart disease, stroke, amputation, kidney disease, blindness and death.

“Preventing diabetes in predominately African American communities’ starts with raising awareness, and educating people with pre-diabetes to change their lifestyle in order to decrease their risk of getting the disease,” says Dr. Nunlee-Bland. “For individuals that have diabetes, there is an abundance of programs and resources available to help manage the disease.”

Dr. Nunlee-Bland suggests diabetes care is complex but can be successfully managed using a multidisciplinary approach. The Howard University Hospital Diabetes Treatment Center provides patients with a team of endocrinologists, educators, pharmacists, and nutritionists to help diabetes patients become more knowledgeable about all aspects of the disease.

https://www.biospace.com/article/releases/in-d-c-diabetes-is-twice-the-national-average-east-of-the-river/

LYNPARZA OK’d in Japan as first-line maintenance therapy for ovarian cancer

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has approvedLYNPARZA, jointly developed by AstraZeneca (NYSE:AZN) and Merck (NYSE:MRK), as a maintenance treatment after first-line chemotherapy in patients with BRCA-mutated (BRCAm) ovarian cancer.

LYNPARZA is the only PARP inhibitor approved in Japan.

https://seekingalpha.com/news/3472289-lynparza-okd-japan-first-line-maintenance-therapy-ovarian-cancer